Immunization standards

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A system for the prequalification of vaccines for UN supply

WHO provides a service to UNICEF and other UN agencies that purchase vaccines, to determine the acceptability, in principle, of vaccines from different sources for supply to these agencies. The detailed procedure can be found at the link below.

There is an established procedure used by WHO for the initial evaluation of candidate vaccines. Reassessment at regular intervals ensures the continuing quality of vaccines.

The revised prequalification procedure was reviewed and endorsed by the WHO Expert Committee on Biological Standardization in October 2010 and is published in WHO TRS 978, Annex 6
. (effective date: February 2012)

Key elements of the procedure are:

Goals

Vaccines used in immunization programmes are safe and effective.

Vaccine efficacy data and studies are relevant to the target population.